- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06948643
The Effect of Exergames on Sleep Quality (EXSLEEPQUALITY)
April 29, 2025 updated by: Feyza Demir Bozkurt, Bartın Unıversity
The Effect of Exergames on Sleep Quality in Nursing Students: A Randomized Controlled Trial
University students are at risk of developing insufficient sleep and poor lifestyle behaviors.
Sleep-related problems are frequently seen in nursing students.
Regular exercise has a positive effect on sleep quality.
In recent years, developing technological opportunities have led educators to seek different solutions in education, guidance, and counseling services aimed at protecting and improving the health of individuals.
As the popularity of VR technology increases, it has a high potential to increase physical activity and improve sleep quality in university students.
In the current literature, studies examining the level of physical activity and sleep quality of nursing students using VR virtual glasses are limited.
This study aims to examine the effect of virtual reality exercise applications on nursing students' sleep quality and physical activity.
This study was planned as a pre-test and post-test control group study.
The study population comprises 60 students from the Department of Nursing and the Faculty of Health Sciences.
Since the study population is accessible, no sample calculation will be made, and all students who volunteer to participate in the study and meet the inclusion criteria will be included.
Randomization will divide students who meet the inclusion criteria into experimental and control groups.
The aim of the study and the application will be explained to the students in the experimental group at the first meeting.
They will be asked to sign written informed consent, and they will fill out data collection forms.
Three sessions are planned for each student in the experimental group.
Each session is planned to be held with an average interval of 96-120 hours (every 4-5 days).
Data collection forms will be repeated for the students in the experimental group at the end of the third session.
The aim of the study will be explained to the students in the control group at the first meeting.
They will be asked to sign written informed consent, and they will fill out data collection forms.
At the end of 14 days, actigraphs will be received from the control group, and post-tests will be applied.
Descriptive statistics of the study data will be reported by giving numbers, percentages, mean, and standard deviation.
Student t-tests, ANOVA or Mann-Whitney U, and Kruskal Wallis tests will be used to compare groups regarding the normal distribution of the data.
Pearson chi-square test and Fisher exact chi-square test will be used to compare nominal or ordinal data groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bartın, Turkey
- Bartın University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being a nursing program student,
- Willingness to participate in the study.
Exclusion Criteria:
- Having any cardiovascular, cerebrovascular, or other physical conditions that could prevent participation in a 30-minute exercise session.
- Being diagnosed with a sleep disorder
- Using medications that effect sleep, the autonomic nervous system, or the cardiovascular system, such as hypnotics
- Having any upper extremity injury or similar condition that would prevent the use of an actigraph device
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Play the Oculus Quest 2 games
|
Every three to four days (roughly 72 to 96 18 19 hours), a session was held.
Students were required to use the Oculus Quest 2 and touch controllers to play immersive exergames for thirty minutes during each session.
In each session, they were asked to play the games Dance Central (https://www.dancecentral.com/ ) and CREED: Rise to Glory (which the researchers loaded into the Oculus Quest 2) via the Meta Quest Gaming platform (https://www.meta.com/tr-tr/experiences/creed-rise-to27
glory-championship-edition/2366245336750543/ ).
|
|
No Intervention: Control
Standard physical activity recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep quality
Time Frame: Baseline and 8th day
|
Pittsburgh Sleep Quality Index (PSQI): The Pittsburgh Sleep Quality Index (PSQI), developed by Buysse et al. and validated for reliability in Turkish, will be used to assess the usual sleep quality of the experimental and control groups to evaluate their homogeneity before the intervention (Ağargün et al., 1996).
The PSQI evaluates seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
The sum of these seven components forms the total PSQI score.
The total PSQI score ranges from 0 to 21, with lower scores indicating better sleep quality.
|
Baseline and 8th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep efficiency
Time Frame: Baseline and 8th day
|
Wrist actigraphy: Wrist actigraphy was used to assess the objective sleep, which is frequently used to assess each person's level of physical activity and sleep quality in adults.
Each participant in the study wore an actigraph (GT3X-Plus three-axis model, ActiGraph LLC, Pensacola, FL, USA) on their non-dominant wrist.
The device was adjusted to 1-minute epochs and 30 Hz in the current study.
Activity counts were analyzed using ActiLife software (version 6.13.6) based on the sleep diary entries, and the Cole-Kripke algorithm was used to score sleep on actigraphy data in order to predict bedtime and waking time.
The following metric was extracted from the actigraphy-based data: sleep efficiency (SE).
|
Baseline and 8th day
|
|
Wake after sleep onset (WASO)
Time Frame: Baseline and 8th day
|
Wrist actigraphy: Wrist actigraphy was used to assess the objective sleep, which is frequently used to assess each person's level of physical activity and sleep quality in adults.
Each participant in the study wore an actigraph (GT3X-Plus three-axis model, ActiGraph LLC, Pensacola, FL, USA) on their non-dominant wrist.
The device was adjusted to 1-minute epochs and 30 Hz in the current study.
Activity counts were analyzed using ActiLife software (version 6.13.6) based on the sleep diary entries, and the Cole-Kripke algorithm was used to score sleep on actigraphy data in order to predict bedtime and waking time.
The following metric was extracted from the actigraphy-based data: wake after sleep onset (WASO).
|
Baseline and 8th day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
June 1, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
April 21, 2025
First Posted (Actual)
April 29, 2025
Study Record Updates
Last Update Posted (Actual)
May 1, 2025
Last Update Submitted That Met QC Criteria
April 29, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BU-NURSE-FDB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nursing Students
-
Şahide AkbulutCompleted
-
Marmara UniversityNot yet recruitingNursing Education | Nursing Students | Nursing ModelTurkey
-
Bilecik Seyh Edebali UniversitesiCompletedEducation, Nursing | Students, NursingTurkey
-
Gazi UniversityNot yet recruiting
-
Bilecik Seyh Edebali UniversitesiCompleted
-
KTO Karatay UniversityCompleted
-
Inonu UniversityCompleted
-
Çankırı Karatekin UniversityCompleted
-
Ege UniversityCompletedNursing StudentsTurkey
Clinical Trials on Play the Oculus Quest 2
-
Hadassah Medical OrganizationRecruiting
-
University of ArkansasRecruitingEndocervical CancerUnited States
-
Oregon Health and Science UniversityCompletedPain, Postoperative | Anxiety | Surgery | Otolaryngological DiseaseUnited States
-
Shifa Tameer-e-Millat UniversityRecruiting
-
Sunnaas Rehabilitation HospitalNorwegian University of Science and Technology; Oslo Metropolitan UniversityRecruitingStroke | Brain Diseases | Brain Injuries | Traumatic Brain Injury | Acquired Brain InjuryNorway
-
Claudio PedoneRecruitingRehabilitation | Virtual Reality | Shoulder Arthroplasty | Malnutrition ElderlyItaly
-
Teesside UniversityCompletedHealthy | Physical Activity | Virtual Reality | Inactivity, Physical | ExergameUnited Kingdom
-
Jimma UniversityHasselt UniversityEnrolling by invitation
-
Escoles Universitaries GimbernatCompleted
-
VA Office of Research and DevelopmentCompleted